Vivos Inc. Submitted the Investigational Device Exemption Application for Human Clinical Trials at Mayo Clinic
Vivos Inc., a pioneer in Precision Radionuclide Therapy (PRnT) solutions, recently announced the submission of its Investigational Device Exemption (IDE) application to the US FDA for RadioGel, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in Vivos Inc.’s mission to provide innovative cancer treatments.
RadioGel is a novel medical device that enables precise radiation delivery to tumors, while minimizing damage to surrounding healthy tissue. The IDE application, developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, addresses regulatory concerns with robust evidence of RadioGel’s safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs.
“This is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA,” said Dr. Michael Korenko, CEO of Vivos Inc. “The strong evidence of RadioGel’s safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need.”
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